Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs

Clinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a regulatory requirement. In order to foster flexible yet rigorous biomarker method validation, the f...

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Detalles Bibliográficos
Autores principales: Cummings, J, Raynaud, F, Jones, L, Sugar, R, Dive, C
Formato: Texto
Lenguaje:English
Publicado: Nature Publishing Group 2010
Materias:
Minireview
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2990602/
https://www.ncbi.nlm.nih.gov/pubmed/20924371
http://dx.doi.org/10.1038/sj.bjc.6605910
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author Cummings, J
Raynaud, F
Jones, L
Sugar, R
Dive, C
author_facet Cummings, J
Raynaud, F
Jones, L
Sugar, R
Dive, C
author_sort Cummings, J
collection PubMed
description Clinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a regulatory requirement. In order to foster flexible yet rigorous biomarker method validation, the fit-for-purpose approach has recently been developed. This minireview focuses on many of the basic issues surrounding validation of biomarker assays utilised in clinical trials. It also provides an overview on strategies to validate each of the five categories that define the majority of biomarker assays.
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spelling pubmed-29906022011-10-26 Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs Cummings, J Raynaud, F Jones, L Sugar, R Dive, C Br J Cancer Minireview Clinical development of new anticancer drugs can be compromised by a lack of qualified biomarkers. An indispensable component to successful biomarker qualification is assay validation, which is also a regulatory requirement. In order to foster flexible yet rigorous biomarker method validation, the fit-for-purpose approach has recently been developed. This minireview focuses on many of the basic issues surrounding validation of biomarker assays utilised in clinical trials. It also provides an overview on strategies to validate each of the five categories that define the majority of biomarker assays. Nature Publishing Group 2010-10-26 2010-10-05 /pmc/articles/PMC2990602/ /pubmed/20924371 http://dx.doi.org/10.1038/sj.bjc.6605910 Text en Copyright © 2010 Cancer Research UK https://creativecommons.org/licenses/by/4.0/This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made.The images or other third party material in this article are included in the article’s Creative Commons license, unless indicated otherwise in a credit line to the material.If material is not included in the article’s Creative Commons license and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder. To view a copy of this license, visit https://creativecommons.org/licenses/by/4.0/.
spellingShingle Minireview
Cummings, J
Raynaud, F
Jones, L
Sugar, R
Dive, C
Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
title Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
title_full Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
title_fullStr Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
title_full_unstemmed Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
title_short Fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
title_sort fit-for-purpose biomarker method validation for application in clinical trials of anticancer drugs
topic Minireview
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC2990602/
https://www.ncbi.nlm.nih.gov/pubmed/20924371
http://dx.doi.org/10.1038/sj.bjc.6605910
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